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Federal Register

Guide on Instructions for Use Patient Labeling

Federal Register notice: FDA makes available a final guidance entitled Instructions for UsePatient Labeling for Human Prescription Drug and Biological...

Human Drugs

Provepharm NDA for Bludigo Approved

FDA approves a Provepharm NDA for Bludigo (indigotindisulfonate sodium), a diagnostic dye indicated for use as a visualization aid in the cystoscopic ...

FDA General

House Urges Senate to Pass User Fee Reauthorization

The House Energy and Commerce Committee leadership calls on the Senate to urgently reauthorize FDAs user fee programs.

Human Drugs

Hospira Recalls 1 Propofol Lot

Hospira recalls one lot of propofol injectable emulsion due to the presence of a visible particulate in a single retained vial from the lot.

Medical Devices

FDA Wants Patient Safety Info on Software Functions

FDA solicits comments on software functions excluded from the medical device definition by the 21st Century Cures Act.

Human Drugs

Drug Instructions for Use Guidance

FDA publishes a guidance on the content and format of patient instructions for use documents for prescription drugs and biologics.

Federal Register

Genentechs Enspryng Regulatory Review Period

Federal Register notice: FDA determines for patent extension purposes the regulatory review period for Genentechs Enspryng (satralizumab-mwge).

Federal Register

Regulatory Review Period for Glaxos Blenrep

Federal Register notice: FDA determines for patent extension purposes the regulatory review period for GlaxoSmithKlines Blenrep (belantamab mafodotin-...

Human Drugs

Summit Considering Additional Ridinilazole Trial

Summit Therapeutics says it is considering whether to hold at least one more clinical trial of its C. Diff treatment radinilazole as discussed at a me...

Human Drugs

Teva Asks Supreme Court to Hear Coreg Skinny Label Appeal

Teva asks the Supreme Court to hear its appeal of an Appeals Court decision invalidating its skinny label on a generic version of GlaxoSmithKlines Cor...